A Long-term Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis
Phase 3
Completed
- Conditions
- Allergic Conjunctivitis
- Interventions
- Drug: DE-114 ophthalmic solution
- Registration Number
- NCT01363713
- Lead Sponsor
- Santen Pharmaceutical Co., Ltd.
- Brief Summary
Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with allergic conjunctivitis, in an open-label, multicenter study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
- Provided signed, written informed consent.
- Has a positive result from a Type I allergy test.
- If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.
Exclusion Criteria
- Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
- Presence of any abnormality or significant illness that could be expected to interfere with the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 DE-114 ophthalmic solution -
- Primary Outcome Measures
Name Time Method Change in Ocular Itching Score by Visit From baseline to 8-week Change from baseline in the average of Ocular itching score over the past 3 days. Ocular itching was assessed by the subject and graded on a 5 points scale of 0-4 (0=no itching, 4=incapacitating itch).
The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Santen study sites
🇯🇵Osaka, Japan